The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
171
Sublingual micro-dosing for 7 days
sublingual dosing for 7 days
University of Kentucky College of Dentistry/Center for Oral Health Research
Lexington, Kentucky, United States
School of Dental Medicine, University at Buffalo
Buffalo, New York, United States
Family Dentistry
Norwich, New York, United States
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, United States
Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).
Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.
Time frame: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)
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